Spots Global Cancer Trial Database for Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia
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Trial Identification
Brief Title: Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Newly Diagnosed, Previously Untreated Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy
Study ID: NCT05079230
Conditions
Study Description
Brief Summary: The goal of this clinical study is to compare the study drugs, magrolimab + venetoclax + azacitidine, versus placebo + venetoclax + azacitidine in participants with untreated acute myeloid leukemia (AML) who are not able to have chemotherapy.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
City of Hope (City of Hope National Medical Center, City of Hope Medical Center), Duarte, California, United States
Community Cancer Institute, Fresno, California, United States
UC Irvine Health- Chao Family Comprehensive Cancer Center, Orange, California, United States
Baptist MD Anderson Cancer Center, Jacksonville, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Loyola University Medical Center, Maywood, Illinois, United States
Parkview Research Center, Fort Wayne, Indiana, United States
Indiana Blood and Marrow Transplantation - Clinic, Indianapolis, Indiana, United States
The University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
University of Maryland, Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, United States
University of Massachusetts Worcester, Worcester, Massachusetts, United States
MidAmerica Division, Inc., c/o Research Medical Center, Kansas City, Missouri, United States
SSM Health Saint Louis University Hospital, Saint Louis, Missouri, United States
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
New York-Presbyterian/Weill Cornell Medical Center, New York, New York, United States
Icahn School of Medicine at Mount Sinai and The Mount Sinai Hospital, New York, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
UNC Hospitals, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
Novant Health Cancer Institute Hematology- Charlotte, Charlotte, North Carolina, United States
Novant Health Cancer Institute Hematology - Forsyth, Winston-Salem, North Carolina, United States
Wake Forest Baptist Health, Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
OU Health Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Providence Cancer Institute Franz Clinic, Portland, Oregon, United States
Penn State Hershey Medical Center, Hershey, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
West Penn Hospital, Pittsburgh, Pennsylvania, United States
Rhode Island Hospital, Providence, Rhode Island, United States
Baylor University Medical Center, Dallas, Texas, United States
Brooke Army Medical Center, Fort Sam Houston, Texas, United States
Houston Methodist Hospital Cancer Center, Houston, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Intermountain Health - LDS Hospital, Salt Lake City, Utah, United States
Virginia Mason Franciscan Health, Seattle, Washington, United States
Fred Hutchinson Cancer Center, Seattle, Washington, United States
Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Canberra Hospital, Woden, Australian Capital Territory, Australia
Border Medical Oncology Research Unit, Albury, New South Wales, Australia
Concord Repatriation General Hospital, Concord, New South Wales, Australia
Liverpool Hospital, Liverpool, New South Wales, Australia
St George Hospital, Clinical Research Unit Haemotology, Division of Cancer Services, Sydney, New South Wales, Australia
Gold Coast University Hospital, Southport, Queensland, Australia
Monash University, Eastern Health-Box Hill Hospital, Box Hill, Victoria, Australia
Northern Health, Epping, Victoria, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Ordensklinikum Linz GmbH Elisabethinen, Linz, , Austria
Hanusch Krankenhaus, Vienna, , Austria
Wiener Gesundheitsverbund, Klinik Hietzing, Wien, , Austria
Ziekenhuis Netwerk Antwerp (ZNA) - Stuivenberg, Antwerp, , Belgium
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
University Hospital Gent, Gent, , Belgium
Hopital de Jolimont, Haine-Saint-Paul, , Belgium
University Hospital Leuven (UZ Leuven) - Campus Gasthuisberg, Leuven, , Belgium
Centre Hospitalier Universitaire de Liege, Liege, , Belgium
Queen Elizabeth II (QEII) Health Sciences Centre, Halifax, , Canada
Centre Integre Universitaire de Sante et de Services Sociaux(CIUSSS) de l'Est-de-L'Ile-de- Montreal - Hopital Maisonneuve-Rosemont, Montreal, , Canada
Princess Margaret Cancer Centre - University Health Network, Toronto, , Canada
CancerCare Manitoba, Winnipeg, , Canada
Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika FN Brno a LF MU, Jihormoravsky KRAJ, , Czechia
Fakultni nemocine Olomouc, Hemato-onkologicka klinika, Olomouc, , Czechia
Fakultni nemocnice Ostrava, Klinika hematoonkologie, Ostrava, , Czechia
Fakulti nemocnice Kralovske Vinohrady, Internf hematologicka klinika FNKV a 3. LF UK, Prague, , Czechia
Vseobecna fakultni nemocnice v Praze, Fakultni poliklinika, Hematologicka ambulance, Praha 2, , Czechia
CHU Amiens Picardie, Amiens Cedex 1, , France
CHU d'Angers, Angers, , France
Hopital Avicenne, Bobigny, , France
Hopitaux Universitaires Henri Mondor, Creteil, , France
Centre Hospitalier Universitaire Grenoble Alpes, La Tronche, , France
Centre Hospitalier de Versailles, Le Chesnay Cedex, , France
Hôpital Claude Huriez (CHRU de Lillle), Lille Cedex, , France
Centre Leon Berard, Lyon Cedex 08, , France
Centre Hospitalier Universitaire Nantes - Hotel Dieu, Nantes, , France
Hopital Saint-Louis, Paris, , France
Centre Hospitalier Lyon-Sud (CHLS), Pierre-Bénite, , France
Institut de Cancérologie Strasbourg Europe (ICANS), Strasbourg, , France
Institut Universitaire du Cancer de Toulouse (IUCT)-Oncopole, Toulouse, , France
CHU de Nancy - Hopitaux de Brabois, Vandoeuvre-les-Nancy, , France
Charite - Universitatsmedizin Berlin, Campus Virchow Klinikum, Medizinische Klinik mit Schwerpunkt Hamatologie, Onkologie und Tumorimmunologie, Berlin, , Germany
Universitätsklinikum Bonn, Bonn, , Germany
Städtisches Klinikum Braunschweig GmbH Medizinische Klinik III/Hämatologie und Onkologie, Braunschweig, , Germany
Universitatsklinikum Dusseldorf, Klink fur Hamatologie, Onkologie und Klinische Immunologie, Dusseldorf, , Germany
Marien Hospital Dusseldorf GmbH, Klinik Fur Onkologie, Hamatologie Und Palliativmedizin, Düsseldorf, , Germany
Malteser Krankenhaus St. Franziskus Hospital,Med.Klinik I, Flensburg, , Germany
Universitatsklinikum Frankfurt Goethe Universitat Med. Klink II, Frankfurt, , Germany
Asklepios Klink St.Georg, Hamburg, , Germany
Medizinische Hochschule Hannover, Hamatologie, Hamostaseologie, Onkologie und Stammzelltrandsplantation, Hannover, , Germany
Universitätsklinikum Magdeburg, Magdeburg, , Germany
Johannes Wesling Klinikum Minden Universitätsklinik fur Hämatologie, Onkologie, Hämostaseologie und Pastativrndezin, Universitatsklinik der Ruhr-Unive, Minden, , Germany
Klinikum rechts der Isar Technischen Universitat Munchen, Muenchen, , Germany
Klinikum Oldenburg, Rahel-Straus-Straße 10, Oldenburg, , Germany
Universitatsklinikum Regensburg, Klink fur Innere Medizin III, Regensburg, , Germany
Universitatsklinikum Ulm, Zentrum fur Innere Medizin, Klinik fur Innere Medizin III, Ulm, , Germany
Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong, , Hong Kong
Princess Margaret Hospital, Hong Kong, , Hong Kong
Queen Mary Hospital, Hong Kong, , Hong Kong
Tuen Mun Hospital, Hong Kong, , Hong Kong
Semmelweis Egyetem Belgyogyaszati es Hematologiai Klinika, Budapest, , Hungary
Petz Aladár Egyetemi Oktató Kórház II. Belgyógyaszat - Haematológia, Gyor, , Hungary
Debreceni Egyetem Klinikai Központ Belgyogyaszati Klinika B epulet Hematologia, Hajdu-bihar, , Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Kozpont, Szeged, , Hungary
Rambam Health Care Campus, Haifa, , Israel
Shaare Zedek Medical Center, Jerusalem, , Israel
Hadassah University Hospital Ein Kerem, Jerusalem, , Israel
Rabin Medical Center, Petah Tikva, , Israel
The Chaim Sheba Medical Center, Ramat Gan, , Israel
Azienda Ospedaliero Universitaria delle Marche - SOD Clinica di Ematologia, Ancona, , Italy
ASST Papa Giovanni XXIII, Bergamo, , Italy
Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi, Bologna, , Italy
IRCCS Istituto Clinico Humanitas, Milano, , Italy
ASST Monza-Ospedale San Gerardo, Monza, , Italy
Azienda Ospedaliera di Perugia - Santa Maria della Misericordia, Perugia, , Italy
Azienda Sanitaria Territoriale Pesaro e Urbino - "Stabilimento Ospedaliero San Salvatore - Muraglia" - U.O. Ematologia e Centro Trapianti, Pesaro, , Italy
Seoul National University Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea Seoul Saint Mary's Hospital, Seoul, , Korea, Republic of
Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, , Netherlands
Meander Medisch Centrum, Amersfoort, , Netherlands
Amsterdam Universitair Medische Centra-Locatie Vrije Universiteit Medisch Centrum, Amsterdam, , Netherlands
Amphia Hospital, department Oncologie, Route 43, Breda, , Netherlands
HagaZiekenhuis, Den Haag, , Netherlands
Medisch Spectrum Twente - Enschede Koningsplein, Enschede, , Netherlands
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
Medisch Centrum Leeuwarden, Leeuwarden, , Netherlands
Masstricht Universitair Medisch Centrum, Maastricht, , Netherlands
St. Antonius Ziekenhuis, Nieuwegein, Nieuwegein, , Netherlands
Canisius Wilhelmina Ziekenhuis, Nijmegen, , Netherlands
Erasmus Medisch Centrum, Rotterdam, , Netherlands
Oslo University Hospital, Department of Hematology, Oslo, , Norway
Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli, Oddzial Hematologiczny, Lublin, , Poland
Szpital Wojewodozki w Opolu Sp. z 0.0. Oddzial Klinixzny Hematologii, Onkologii Hematologicznej i Chorob Wemnetrznych, Opole, , Poland
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M.Kopernika w Lodzi, Oddzial Hematologii Ogolnej, Łódź, , Poland
Hospital Universitario Araba, Alava, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital Universitario Reina Sofia, Cordoba, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Universitario Quironsalud Madrid, Madrid, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Regional Universitario de Malaga, Malaga, , Spain
Complejo Asistencial Universitario de Salamanca - Hospital Clinico, Salamanca, , Spain
Complejo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, , Spain
Hospital Universitari I Politecnic La Fe, Valencia, , Spain
Inselspital Universitätsspital Bern, Berne, , Switzerland
Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
National Cheng Kung University Hospital, Taipei, , Taiwan
Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, , United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, , United Kingdom
Leeds Teaching Hospitals NHS Trust, Leeds, , United Kingdom
Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool, , United Kingdom
Barts Health NHS Trust, London, , United Kingdom
King's College Hospital, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Newcastle upon Tyne Hospitals Foundation Trust, Newcastle upon Tyne, , United Kingdom
Oxford University Hospitals NHS Foundation Trust, Churchill Hospital, Oxford, , United Kingdom
South Warwickshire University NHS Foundation Trust, Warwick, , United Kingdom
The Royal Wolverhampton NHS Trust, Wolverhampton, , United Kingdom
Contact Details
Name: Gilead Study Director
Affiliation: Gilead Sciences
Role: STUDY_DIRECTOR
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